CROSSLEAD Penetration Peripheral Guide Wire

{0}------------------------------------------------ July 20, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. ASAHI INTECC Co., Ltd. Cynthia Valenzuela Director, Regulatory Affairs 3002 Dow Avenue. Suite 212 Tustin, California 92780 Re: K230377 Trade/Device Name: CROSSLEAD Penetration Peripheral Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: July 3, 2023 Received: July 3, 2023 ### Dear Cynthia Valenzuela: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Samuel G. Raben -S for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use #### Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K230377 Device Name CROSSLEAD Penetration Peripheral Guide Wire Indications for Use (Describe) This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ 510(k) Summary [as required by 21CFR § 807.92(c)] ## ΛՏΛΗΙ INTECC CO.,LTD. Global Headquarters and R&D Center 3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan TEL: +81-561-48-5551 FAX: +81-561-48-5552 http://www.asahi-intecc.co.jp/ #### CROSSLEAD Penetration Peripheral Guide Wire 510(k) | DATE PREPARED: | 16FEB2023 | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | APPLICANT: | ASAHI INTECC CO., LTD.<br>3-100 Akatsuki-cho, Seto<br>Aichi 489-0071, Japan | | PRIMARY CONTACT: | Mrs. Cynthia Valenzuela<br>Director, Quality System, Regulatory Affairs & Regulatory Compliance<br>ASAHI INTECC USA, INC.<br>3002 Dow Avenue, Suite 212<br>Tustin, California 92780<br>Phone: (714) 442 0575<br>Mobile: (949) 745 1617<br>Email: cynthiav@asahi-intecc-us.com | | ALTERNATE CONTACT: | Mr. Hiroshi Obara<br>Manager, Regulatory Affairs<br>ASAHI INTECC CO., INC.<br>3-100 Akatsuki-cho<br>Seto, Aichi, Japan 489-0071<br>Email: hiroshi.obara@asahi-intecc.com | | TRADE NAME: | CROSSLEAD Penetration Peripheral Guide Wire | | DEVICE CLASSIFICATION: | Class II, 21CFR § 870.1330 | | CLASSIFICATION NAME: | Catheter Guide Wire | | PRODUCT CODE: | DQX | | PREDICATE DEVICE(S): | ASAHI Peripheral Guide Wire ASAHI Astato XS 40<br>(K153443) | | REFERENCE DEVICE(S): | ASAHI Peripheral Guide Wire ASAHI Halberd (K150445)<br>CROSSLEAD Peripheral Guide Wire (K213315) | #### Intended Use/Indications for Use: This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. {4}------------------------------------------------ ### Description: The CROSSLEAD Penetration Peripheral Guide Wire (hereafter "CROSSLEAD Penetration") is steerable guide wire with a maximum diameter of 0.014" (0.36 mm) and 0.018" (0.46 mm) and available in 200 cm, 235 cm and 300 cm length. The guide wire is constructed from a stainless steel core wire with a Pt-Ni-Au alloy coil. The coil is soldered to the core wire with Au-Sn solder. The coil has radio - detectability to achieve visibility and can be made to bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction, and coating of the CROSSLEAD Penetration are similar to that previously described in the predicate ASAHI Peripheral Guide Wire ASAHI Astato XS 40 (K153443) (hereafter "ASAHI Astato XS 40") and reference CROSSLEAD Peripheral Guide Wire (K213315) (hereafter "CROSSLEAD").and ASAHI Peripheral Guide Wire ASAHI Halberd (K150445) (hereafter "ASAHI Halberd").. ### Accessory There are no accessories packed with CORSSLEAD Penetration. | Predicate | Device Name | 510(K) Number | |-------------------|--------------------|---------------| | Primary Predicate | ASAHI Astato XS 40 | K153443 | | Reference Device | CROSSLEAD | K213315 | | Reference Device | ASAHI Halberd | K150445 | ### Comparison with Predicate Device and Reference Device: The subject device has the following similarities to those which previously received 510(k) clearance. - Have the similar intended use and indications for use ● - Use the same operating principle; ● - . Incorporate the same basic designs; and - . Incorporate the same materials {5}------------------------------------------------ ### Comparison with Predicate Device and Reference Device | Name of Devices | CROSSLEAD Penetration | ASAHI Astato XS 40 | CROSSLEAD | ASAHI Halberd | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject | Predicate | Reference | Reference | | 510(k) | TBD | K153443 | K213315 | K150445 | | Manufacturer | ASAHI INTECC | ASAHI INTECC | ASAHI INTECC | ASAHI INTECC | | Classification | 21 CFR 830.1330, Cardiovascular | | | | | Regulation. | | | | | | Common Name | Catheter Guide Wire | | | | | Product Code | DQX | | | | | Class | II | | | | | Intended Use | | Guide wire for percutaneous intervention | | | | Indications for Use | This product is designed to<br>direct a catheter to the<br>desired anatomical location<br>in the peripheral vasculature<br>during diagnostic or<br>interventional procedures. | This product is intended to<br>facilitate the placement and<br>exchange of diagnostic and<br>therapeutic devices during<br>intravascular procedures.<br>This device is intended for<br>peripheral vascular use only. | This product is designed to<br>direct a catheter to the<br>desired anatomical location<br>in the peripheral vasculature<br>during diagnostic or<br>interventional procedures. | This product is intended to<br>facilitate the placement and<br>exchange of diagnostic and<br>therapeutic devices during<br>intravascular procedures.<br>This device is intended for<br>peripheral vascular use only. | | Nominal OD<br>(Maximum) | 0.36 mm (0.014")<br>0.46 mm (0.018") | 0.36 mm (0.014") | 0.89 mm (0.035") | 0.36 mm (0.014")<br>0.45 mm (0.018") | | Overall Length | 200 cm, 235 cm, 300 cm | 200 cm, 300 cm | 200 cm, 300 cm | 200 cm, 235 cm, 300 cm | | Coil | Pt-Ni-Au | Pt-Ni | SUS | Pt-Ni | | Core Wire | SUS | SUS | Ni-Ti alloy | SUS | | Solder | Au-Sn | Ag-Sn<br>Au-Sn | Ag-Sn<br>Au-Sn | Ag-Sn | | Tip Shape | Straight, Pre-shape | Straight | Straight, Angled | Straight, Pre-shape | | Coating | <Distal> Hydrophilic<br><Proximal> Hydrophobic | <Distal> Hydrophilic<br><Proximal> Hydrophobic | <Distal> Hydrophilic<br><Proximal> Hydrophobic | <Distal> Hydrophilic<br><Proximal> Hydrophobic | | Sterilization | Provided sterile via Ethylene<br>Oxide to SAL 10-6 | Provided sterile via Ethylene<br>Oxide to SAL 10-6 | Provided sterile via Ethylene<br>Oxide to SAL 10-6 | Provided sterile via Ethylene<br>Oxide to SAL 10-6 | {6}------------------------------------------------ ### Non Clinical Testing / Performance Data: The substantial equivalence of the CROSSLEAD Penetration was evaluated in bench testing that followed the recommendations in the FDA guidance document; Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 15JUN2018. - Tensile Strength - Torque Strength ● - Torqueability ● - Tip Flexibility ● - Coating Integrity ● - Catheter Compatibility - Appearance and Cleanliness ● - Corrosion Resistance ● - Kink Resistance - Radio - detectability - Dimensional Verification ● - Coating Integrity/Particulate Evaluation in a clinically relevant mode ● The in vitro bench tests demonstrated that the CROSSLEAD Penetration met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate device. #### BIOCOMPATIBILITY: The CROSSLEAD Penetration was tested in accordance with ISO 10993, and found to be biocompatible. The following tests were performed: | Test | Test Summary | Conclusion | |------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | Cytotoxicity - ISO 10993-5<br>L929 cells/MEM Elution Test | The test system is considered suitable if no<br>signs of cellular reactivity (Grade 0) are noted<br>for both the negative control article and the<br>medium control. | Non-cytotoxic | | Sensitization - ISO 10993-10<br>KLIGMAN Maximization Test | The extracts should show no evidence of<br>causing delayed dermal contact sensitization<br>in the guinea pig. | Non-sensitizer | | Irritation - ISO 10993-23<br>Intracutaneous Injection Test | The test extract and the negative control must<br>exhibit similar edema and erythema scores. | Non-irritant | | Systemic Toxicity - ISO 10993-11<br>Acute System Toxicity Test | The test article must not show significantly<br>greater biological activity than the control. | Non-toxic | | Systemic Toxicity - ISO 10993-11<br>Rabbit Pyrogen Test (material<br>mediated) | The test article should not increase the rectal<br>temperature of any of the animals by more<br>than 0.5 degrees Celsius. | Non-pyrogenic | | Hemocompatibility - ISO 10993-4<br>Rabbit Blood Hemolysis Test | Test article in direct contact with blood and<br>test article extract must be non-hemolytic. | Non-hemolytic | | Hemocompatibility - ISO 10993-4<br>Unactivated Partial Thromboplastin<br>Time Test | The UPTT of the plasma exposed to test<br>article extract should not significantly<br>decreased when compared to untreated and<br>negative controls. | Not an activator | | Hemocompatibility - ISO 10993-4<br>Complement Activation Assay<br>(SC5b-9) | The plasma exposed to test article must<br>exhibit no significant increase in SC5b-9 when<br>compared to activated NHS and negative<br>control after 60 minutes exposure. | Not an activator | | Hemocompatibility - ISO 10993-4<br>Thrombogenicity Study in Dogs | Compare results of test article to predicate<br>control for Thrombogenic response.<br>Determine acceptability of results as part of<br>risk management. | Thromboresistant | #### Biocompatibility Results (brief) {7}------------------------------------------------ #### CONCLUSION: The CROSSLEAD Penetration has similar intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate and reference device. Performance data demonstrates that the device functions as intended. Therefore, the CROSSLEAD Penetration is substantially equivalent to the predicate device.